Committee publications
Regulatory trends in drug pricing and market access in Argentina
This article analyses the current regulatory trends in Argentina concerning drug pricing and market access. Based on the complex structure of the Argentine healthcare system, the strategies employed by pharmaceutical companies and healthcare payers, the existing legal frameworks and the role of institutions, such as CONETEC and CATPROS, are discussed. The article also highlights the recent initiative to create a new national health technology assessment agency (ANEFiTS), which could redefine the rules governing access, coverage and pricing in the country.
Released on Jun 2, 2025
The impact of the NIS2 Directive: will hospital CEOs have to become cybersecurity experts?
This article explores the new legal environment in the European Union arising from the revised Network and Information Security Directive (NIS2), which is applicable to the management boards of health sector services providers, notably hospitals and clinics. This EU Directive establishes a new set of obligations, which makes board members directly and personally responsible for the level of cybersecurity compliance by the entities that they manage and administer, as well as making them responsible for the cybersecurity failures the entities may suffer. This article emphasises the importance of management boards designing and adopting strict cybersecurity policies and internal control systems to ensure compliance with the EU Directive and to avoid any liabilities.
Released on Jun 2, 2025
Strategies for managing scarcity and shortages in the supply of drugs, medical devices and other essential goods: insights from the Ecuadorian context
The scarcity and shortage of drugs, medical devices and other essential health-related goods in Ecuador reflects a structural crisis that undermines the healthcare system’s ability to meet public needs. This article explores the complex causes behind these shortages, including flaws in public procurement processes, institutional fragmentation and governance challenges, while analysing their social and economic impacts. It proposes short, medium and long-term strategies and emphasises the need for responsible public debt management and stronger health governance to guarantee sustained and equitable access to critical medical resources.
Released on Jun 2, 2025
Counterfeit pharmaceuticals: innovative strategies for combatting global health threats
Counterfeit pharmaceuticals pose a significant global health threat, endangering millions of lives and undermining public trust in healthcare systems. This article explores the innovative strategies being employed worldwide to combat this issue, such as track-and-trace systems, smart packaging, artificial intelligence (AI)-driven detection and international collaboration. Emphasis is placed on the importance of advanced technologies like blockchain and radio-frequency identification (RFID), which enhance the traceability and authenticity of drugs. Additionally, stronger legal frameworks, public awareness campaigns and efforts to regulate online pharmacies are essential to tackling this problem. By combining these innovations, stakeholders can work towards a more secure pharmaceutical supply chain and improved public health protection.
Released on Jun 2, 2025
Strategies to secure supply chains: effective contractual approaches to overcome scarcity challenges in the supply of drugs, medical devices and other essential goods
Effective supply chain strategies are imperative in mitigating scarcity challenges in the healthcare industry. This article emphasises the importance of robust contractual approaches to ensure a sta-ble and resilient supply chain. Solutions range from the diversification of suppliers to clear quality standards and proactive price clauses. By implementing these contractual safeguards, companies can navigate supply chain complexities, address shortages and foster sustainable partnerships in an evolving healthcare industry. The key lies in crafting agreements that promote flexibility, risk management and performance incentives to enhance overall supply chain resilience.
Released on Jun 2, 2025
The hospital exemption pathway for non-industrially manufactured advanced therapy medicinal products: a fragmented landscape in the face of EU legislative reform
The regulation of advanced therapy medicinal products (ATMPs) under the hospital exemption (HE) scheme in the European Union remains highly fragmented, with national approaches varying significantly. Spain’s model, for instance, closely aligns ATMPs subject to the HE scheme with authorised products. The revision of pharmaceutical legislation aims to standardise the relevant requirements, enhance traceability and clarify the related compliance obligations. However, concerns persist in relation to ambiguous definitions and regulatory gaps. The European Parliament’s amendments have left key issues unresolved. As negotiations continue at the level of the Council of the European Union and trilogues approach, striking a balance between fostering innovation and ensuring regulatory coherence remains a pressing challenge for EU policymakers.
Released on Jun 2, 2025
Three-dimensional printing of medical devices
3D printing can be used to create customised medical devices using patient-specific data. This article addresses the regulatory status of this transformative technique and its development in Argentina. Although there are no regulations specific to 3D printing used in the manufacturing of medical devices, the National Administration of Drugs, Food and Medical Devices has published a guide outlining the key technical considerations for products developed through additive manufacturing, a broad category that includes 3D printing within its scope.
Released on Jun 2, 2025
Sales in law: why great lawyers are already great at sales
Many lawyers feel uncomfortable with the word ‘sales’. The idea of pitching, persuading or promoting can feel unnatural. And it’s no wonder – multiple studies show that salespeople are widely perceived as untrustworthy, and lawyers aren’t rated much higher. The encouraging part, though, is that great lawyers already apply the core principles of good sales. The real shift is in mindset: moving from ‘selling’ to consultative relationship-building – something most great lawyers are already doing when supporting their clients.
Released on May 29, 2025
How to deepen client relationships for lifelong retention
Building long-lasting client relationships is essential for any successful legal practice. While acquiring new clients is important, the true value lies in nurturing relationships over time, creating stability and scalability crucial for long-term success. This guide will help you effectively build and maintain these vital client connections, even with a busy schedule.
Released on May 29, 2025
Constituting tribunals in investment arbitration
The IA Subcommittee has worked with four of the major arbitral institutions administering investment arbitrations to obtain that data and related statistics
Released on May 29, 2025
Getting to Know the ERF – Alessandro Barzaghi
Get to know the European Regional Forum’s Council Member for Italy, Alessandro Barzaghi.
Released on May 28, 2025
Perspectives on the reform proposed to the Brazilian Civil Code for corporate law
In 2025, the Brazilian Congress initiated formal discussions on a bill to substantially amend the Brazilian Civil Code. Among the various topics under consideration are significant changes to Brazilian corporate law. This article provides an overview of the proposed modifications, with a particular focus on their potential impact on foreign companies seeking to invest in Brazil.
Released on May 23, 2025
Material adverse change clauses in M&A: the risks of USMCA renegotiation and tariff uncertainty
This article examines the enforceability of Material Adverse Change (MAC) clauses in scenarios involving tariffs or sudden treaty changes, analysing how courts in the United States and Mexico might assess such enforceability claims under their respective legal systems.
Released on May 23, 2025
Indonesia legal insights: merger filing procedures and requirements in Indonesia in accordance with competition law
Monopolistic practices and/or unfair business competition are subject to heavy scrutiny by the Indonesian Government, especially in the context of transactions involving Mergers and Acquisitions (‘M&A’) where there is a risk that the combined company could result in monopolistic business practice taking place. The Indonesian government has imposed a requirement for companies conducting merger, consolidation or acquisition transactions to file reports of these activities through merger filing to the Business Competition Supervisory Commission (Komisi Pengawas Persaingan Usaha or ‘KPPU’) for approval. This article aims to outline the applicable criteria that require certain transactions to be subject to merger filing, as well as the relevant procedures to be abided by when conducting merger filing.
Released on May 23, 2025
The use of irrevocable PoAs in Ukraine: practical considerations
Ukrainian law permits the use of irrevocable powers of attorney (PoAs). These are governed by the Civil Code of Ukraine as well as the Law of Ukraine On Joint Stock Companies and the Law of Ukraine On Limited Liability Companies and Additional Liability Companies, as applicable. While irrevocable PoAs are allowed in the context of both limited liability companies (LLCs) and joint stock companies, this article focuses on their use in LLC structures, as these represent the most common corporate vehicle for such arrangements in practice.
Released on May 22, 2025
Thirteenth Annual Global Report
The 13th Annual Global Report from the GEI
Released on May 21, 2025
Inspirational legal women: a conversation with Imbi Jürgen
An insightful discussion with Imbi Jürgen
Released on May 20, 2025
The latest updates to the Guest Investor Residency Programme
This article outlines the Hungary’s Guest Investor Programme, known as the Hungarian Golden Visa Programme, and explains that latest updates.
Released on May 19, 2025
Why your due diligence checklist may not work in Mexico
This article delves into the risks that arise heading into closing, which commonly create a no-deal situation. It will walk readers through the most important aspects to have in mind and share practical strategies to build a due diligence checklist that actually works in Mexico – keeping the reader informed, compliant and on track to close on time.
Released on May 19, 2025
Material contract warranties in M&A in India: a shield and a sword
In the intricate dance of mergers and acquisitions (M&A), material contract warranties serve as both a shield and a sword for buyers and sellers. They offer buyers a degree of security about the target company's operational and financial health, while simultaneously protecting sellers from potential future liabilities. Understanding the nuances of these warranties is crucial for navigating the complex landscape of M&A transactions.
Released on May 19, 2025
Relevant tax issues regarding M&A operations
This article examines the critical tax issues that arise in M&A transactions. It begins by outlining the inherent complexities of the tax system, including frequent legislative changes and interpretative discrepancies. Emphasising a preventive approach, the paper highlights the importance of early tax planning to avoid unexpected burdens and penalties, particularly given the high combined rates applicable to legal entities. Key topics include the accounting revaluation process, the treatment of goodwill and gains from bargain purchases, and the implications of deferred payments or contingent considerations. The discussion further covers strategies to optimise tax outcomes through careful negotiation of contractual clauses like indemnification and escrow arrangements. Finally, the article addresses the tax challenges associated with post-closing integration, offering guidance on managing supply chain consolidation, cross-border operations, and system integration issues.
Released on May 19, 2025
Transparency of ownership of property in the UK
The UK has introduced reporting requirements for overseas entities which own or hold a long lease of property in the UK in recent years. The UK Register of Overseas Entities and the Scottish Register of Persons Holding a Controlled Interest in Land aim to increase transparency in relation to ownership of property in the UK and uncover who truly controls that property. Failure to comply with registration and administration requirements can have implications for overseas owners dealing with or acquiring property in the UK.
Released on May 15, 2025
Class actions for consumer protection in Austria: development from a civil law to a case law jurisdiction
Case law plays a significant role in interpreting laws in Austria but does not have a general binding effect (legal precedent). In the last 20 years, the Austrian Supreme Court has handed down several judgments on illegal clauses in leases (with consumers) therewith substantially enhancing the importance of judgments in lease law. As the Supreme Court applies a different test for illegal clauses in class actions, courts may deviate in individual cases making the outcome less predictable for landlords, tenants and the legal profession.
Released on May 15, 2025
The Real Estate Investment Conference – 4–6 June 2025 – London
The 15th Annual IBA Real Estate Investment Conference in London on 4–6 June 2025 is shaping up to be a fantastic opportunity to hear about the latest trends in real estate investment.
Released on May 15, 2025
Navigating the intersection of longevity and real estate: legal and operational considerations for senior living in Portugal
As global demographic trends evolve, the real estate sector must adapt to meet the needs of an aging population. By 2031, it is anticipated that 75 per cent of people will live to at least 80 years old, creating an unprecedented demand for housing solutions that cater to older adults. Senior living concepts are an innovative response to this challenge, designed for independent seniors who seek a vibrant community living experience.
Released on May 15, 2025
Getting to Know the ERF – Julie Book
Get to know the European Regional Forum’s Council Member for England, Julie Book.
Released on May 15, 2025
Getting to Know the ERF – Annalise Papa
Get to know the European Regional Forum’s Treasurer, Annalise Papa.
Released on May 12, 2025
Heritage protection and the role of ISOS in Swiss construction law and urban development
Heritage protection in Switzerland, especially for sites registered in the Federal Inventory of Swiss Heritage Sites (ISOS), has become a central factor in construction law and urban planning. Over the years, case law regarding the applicability of ISOS has significantly expanded its scope, leading to heightened scrutiny of construction projects and stricter requirements for preserving historic landscapes. Tensions between urban densification and heritage protection are accordingly intensifying, as private property rights often yield to public conservation interests.
Released on May 9, 2025
Preparing for ETIAS: how the new rules will affect business travel to the Netherlands
As the European Union rolls out more robust security measures, Dutch companies with international business travellers should be aware of the European Travel Information and Authorisation System (ETIAS). Originally scheduled for implementation on 10 November 2024, ETIAS has been postponed again until the end of 2026, but businesses should still be ready for its implementation.
Released on May 7, 2025
Major recent changes to Canadian immigration
The landscape of Canadian immigration has undergone substantial changes since 2024, affecting various immigration streams and programmes. These changes are part of Canada’s efforts to manage population growth and regain control – what is the government is calling ‘ensuring the sustainability of its immigration system’.
Released on May 6, 2025